Brand

Insulet Corporation Recalls

11 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Insulet Corporation.

11Total Recalls
7Critical
1.7MUnits Affected
Mar 12, 2026Most Recent
All Recalls

Every Insulet Corporation Recall

Sorted by most recent. Click any recall for full details.

11 recalls
CriticalFDA
Insulet Corporation
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Medical Devices·1,240,115 affected·Mar 12, 2026
CriticalFDA
Insulet Corporation
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Packag...
Diabetes Devices·27,000 affected·Nov 30, 2023
High RiskFDA
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System
Diabetes Devices·11,016 affected·Feb 28, 2023
CriticalFDA
Insulet Corporation
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final...
Diabetes Devices·248,288 affected·Oct 17, 2022
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Di...
Diabetes Devices·21,723 affected·Feb 1, 2021
High RiskFDA
Insulet Corporation
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG...
Diabetes Devices·32,756 affected·Feb 13, 2020
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Diabetes Devices·264 affected·Dec 18, 2018
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended ...
Diabetes Devices·5,179 affected·Nov 2, 2015
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intende...
Diabetes Devices·26,230 affected·Nov 2, 2015
CriticalFDA
Insulet Corporation
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous del...
Diabetes Devices·16,017 affected·Jul 13, 2015
CriticalFDA
Insulet Corporation
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous ...
Diabetes Devices·24,829 affected·Jul 13, 2015